IPBiz

Monday, January 29, 2007

Stephen Barr of the Washington Post has an article Patent Backlog Spurs Demand for Examiners which includes text:

The patent office plans to hire 1,200 examiners for each of the next five years. The average starting salary is about $62,000, and electrical engineers and computer engineers may qualify for an $8,800 signing bonus because the PTO has a hard time recruiting in those fields.

(...)

PTO also tries to be a family-friendly employer, giving some leeway to examiners on when they start their work each day -- as long as they meet certain productivity goals, based on their experience and the difficulty of their caseload.

"You have to work hard; it's a difficult job, but if you work hard, you can do the job in 40 hours a week," Doll said.

This is a linguistic search performed by Scientific and Technical Information Center (STIC).

A PLUS search analyzes the words that occur in the background and summary of the invention sections of the specification, as well as the frequency at which those words occur, and compares that with the patent specifications in the patent database. Useful? Well, sometimes yes. However, given the fact that 'the applicant can be their own lexicographer', the PLUS search will never be anything approaching comprehensive. Different applicants will invariably use different terminology. (This is one of the reasons why it is so important to take the time to figure out what the claimed invention is. Pull terms from the claims and drop them into EAST? Don't expect to find useful prior art.)

IPBiz notes that, in contrast, there is only ONE way to say Andersonville and ONE way to say Wirz, so the University of Tennessee had a much easier job.

Sunday, January 28, 2007

Platform Solutions brings antitrust case against IBM

Platform Solutions Inc. (PSI), the mainframe wannabe whose Itanium-based servers can run IBM's z/OS mainframe operating system as well as Windows, Unix and Linux, has sued IBM for antitrust, charging Big Blue with, among other things, tying the sale of z/OS to the sale of its mainframe hardware, a serious antitrust no-no and something IBM is specifically forbidden to do under the lingering terms of its now-dissolved 1956 consent decree with the United States government.

(...)Besides tying and tortuous interference with the potential sale of PSI, the 54-page suit charges IBM with monopolization, attempted monopolization, leveraging a monopoly, maintaining, extending and prolonging a monopoly, denying access to an essential facility, restraining trade, suppressing competition, coercing customers and injuring consumers, as well as exclusionary conduct and unfair or fraudulent business practices that deceive customers and cause "supracompetitively" higher prices that also run into the "hundreds of millions of dollars."

In other words, it throws the book at IBM and charges it with violating Section 1 and Section 2 of the Sherman Antitrust Act, Section 3 of the Clayton Antitrust Act, the California Business and Professions Code and New York General Law.

Nothing in the text of this Rule establishes "general acceptance" as an absolute prerequisite to admissibility. Frye made `general acceptance' the exclusive test for admitting expert scientific testimony. That austere standard, absent from and incompatible with the Federal Rules of Evidence, should not be applied in federal trials. "general acceptance" can yet have a bearing on the inquiry. Widespread acceptance can be an important factor in ruling particular evidence admissible

Possible text in KSR:

Nothing in the text of 35 USC 103 establishes motivation as an absolute prerequisite to establish obviousness. [CAFC/CCPA caselaw] made a showing of motivation a requirement for proving obviousness. That austere standard, absent from the statute and incompatible with case law of the Supreme Court (including Graham v. Deere), should not be applied in federal patent trials. However, motivation can yet have a bearing on the inquiry. The absence of motivation can be an important factor in ruling that a particular combination invention is not obvious.

The IPBiz suggestion is distinct from other suggestions that "motivation" would no longer be the exclusive test. IPBiz thinks it more likely that the Supreme Court will mention factors bearing on obviousness, which factors include motivation (or some word or words meaning the same thing). The past form of the obviousness inquiry of the CAFC won't survive.

In a situation wherein the patent opponent linked disparate prior art to reach the elements of the challenged invention, motivation might be a very important factor. In inventions perceived to be low-level, as the court may perceive the invention involved in KSR v. Teleflex, motivation might not be such an important factor.

IPBiz does not think the suggested outcome is a good thing, but many justices did seemed troubled by the motivation test, possibly influenced by the significant lobbying in the general area of "patent reform." Furthermore, the CAFC did not have an attorney arguing "its" position before the Supreme Court, and its recent rulings (probably designed as a proxy for representation before the court) were ignored.

Saturday, January 27, 2007

The Chronicle of Higher Education wrote on 26 Jan. 07: An investigative committee at Michigan State University found that Prof. Jose B. Cibelli could not reasonably have known of the misconduct, James M. Pivarnik, the university’s intellectual-integrity officer, wrote in a letter to Mr. Cibelli’s colleagues today.

South Korean and US researchers on Wednesday [11 Feb. 2004] said, at the 2004 AAAS Annual Meeting in Seattle (12-16 Feb.), they had cloned a human embryo and extracted from it embryonic stem cells. [IPBiz note: the US connection was Dr. Jose Cibelli, formerly of Advanced Cell Technology and now a researcher at Michigan State University in the US.]

The 2004 press release proclaimed: The experiment, the first published report of cloned human stem cells, means so-called therapeutic cloning is now a reality.

Returning to the present (January 27, 2007), one sees that there still is no therapeutic cloning.

"In terms of the science, it has really taken us back to square one," Dr. Stephen Minger, a stem cell researcher from King College London, told the BBC. "Nobody has got close to doing what Dr. Hwang claimed to have done."

Minger fears that embryonic stem cell science won't any major progress for years to come because there is a lack of human eggs to use in research and obtaining them from women poses numerous ethical problems.

"Hwang seemed to have all the resources and an endless supply of human eggs to use," he told the BBC. "But here and elsewhere people cannot push this field forward because there is a profound shortage of eggs -- and this is a major problem."

Professor Julian Savulescu, from Oxford University, talked about Hwang's downfall in a recent article in the Journal of Medical Ethics and said the conditions that allowed Hwang to conduct his research don't normally exist elsewhere.

Broadcom does NOT infringe Qualcomm patents in videocompression, and users of the H.264 standard are probably safe from the Qualcomm patents at issue in this case. However, there is a lesson in reporting. The LA Times, utilizing Bloomberg, reported that the Qualcomm patents were unenforceable. The issue of "inequitable conduct" is equitable, and juries don't decide it, so the Times got the story wrong. There was an advisory verdict, which may influence the judge when he decides the inequitable conduct matter. The San Diego Union Tribune got the story right.

Bloomberg reported on 27 Jan: Broadcom Corp. didn't infringe two patents owned by rival Qualcomm Inc., a federal jury found Friday in the first trial of the companies' dispute over chips used in computers, DVD players and mobile phones.

The patents, for technology to compress high-definition video, are unenforceable because Qualcomm withheld information from the U.S. Patent and Trademark Office, jurors in San Diego said after six hours of deliberations. But they agreed with Qualcomm that the patents were valid.

Qualcomm, the world's second-biggest maker of mobile- phone chips, was asking for $8.3 million in cash compensation.

(...)

Qualcomm said its patents covered technology needed to comply with an industry standard that allows for transmission of high-quality video over wireless, satellite and Internet connections. Broadcom's chips are used in television set-top boxes, mobile phones and high-definition DVD players.

Qualcomm participated in the group that set the standard, and all members had to agree to license their patents on fair and reasonable terms. As a result, Broadcom contended, Qualcomm didn't have a right to demand a court order and was entitled only to future royalties based on the rate established by the jury for past infringement.

Qualcomm is boosting spending to more than $200 million to litigate patent and other court cases this fiscal year, more than double the amount it spent two years ago, President Steven Altman told analysts Wednesday.

***Kathryn Balint and David Washburn of the Union Tribune reported:

After just six hours of deliberating, a federal jury found yesterday that chip maker Broadcom did not infringe on two patents held by San Diego-based Qualcomm and determined in two advisory votes that Qualcomm had withheld key information from a standards-making body and the patent office.

(...)One of the biggest blows to Qualcomm came in the form of advisory votes, sought by the judge, in which the jury questioned Qualcomm's integrity.

In one advisory vote, the jury found “clear and convincing evidence” that Qualcomm had withheld previous scientific studies on video-compression from the U.S. Patent and Trademark Office when applying for one of the patents in question. The jury's advisory vote said that the patent is “unenforceable due to Qualcomm's inequitable conduct in the patent application process.”

In the second advisory vote, the jury found that Qualcomm had waived its right to enforce both of the patents in the case, because it had failed to inform a standards-making group that it held patents it thought were key to the H.264 standard that was in development. The standard was developed in 2003 by a group of companies to provide better-quality high-definition video.

The votes on those two issues will be taken under advisement by U.S. District Judge Rudi Brewster, who is presiding over the case in federal court in downtown San Diego and who will ultimately decide those questions.

**Elsewhere in the article, there was a suggestion that Qualcomm had nothing to lose-->

"There certainly was a significant upside potential for us, but it was all upside, no downside," said Qualcomm executive vice president and general counsel Lou Lupin.

IPBiz notes that if the judge finds inequitable conduct ALL CLAIMS of the patents will be unenforceable against anybody. One might find this a downside risk.

The patents, for technology to compress high-definition video, are unenforceable because Qualcomm withheld information from the U.S. Patent and Trademark Office, jurors in San Diego said after six hours of deliberations. But they agreed with Qualcomm that the patents were valid.

There is no mention of advisory verdicts, or that this issue is not actually resolved.

A note to californiastemcellreport

There is a Jan. 26 post on californiastemcellreport entitled Ebert on WARF and the Patent Challenge. I've made two comments. The second comment is as follows:

As a follow-up, the remarks of FTCR to the effect that WARF's patents will impede research and innovation sound in deja vu. The same arguments were made about the patent of the Wright Brothers. At that time, the arguments resonated because of World War I, and, (as in the tv commercial) the Wrights got hosed, in that a patent pool was created. Curiously, the pool deterred small inventors, didn't produce a single American fighter plane used in WWI, but did create a huge surplus of planes after the war. [See, for example, Patent Thickets and the Wright Brothers.]

As noted, it is encouraging that californiastemcellreport did discuss the work of Gilbert. However, Gilbert did not get into many of the more scientific issues in embryonic stem cells, such as how the reality of the Hwang fraud is going to impact the therapeutic stem cell time line. Putting aside the "bad apple" issue, one notes 1) that none of Hwang's international scientific peers recognized the bad work (Korean co-workers led the way) and 2) a year has passed but no one has reproduced the work in the first paper, much less the second paper. There are no human SCNT-derived stem cell lines at this time.

The Baker study may well become a poster child for long existent arguments about economists and intellectual property. "George Priest went so far in 1986 as to say that economists could tell lawyers virtually nothing about the appropriate scope of intellectual property rights...." See What have non-technically trained lawyers contributed to IP law?

Both FTCR and californiastemcellreport have linked patent invalidity arguments and licensing policy. A patent is not invalid because of licensing policy of the patentee. FTCR has stated that the WARF patents are somehow bad patents because they are broad. There is currently much discussion about the impact of bad patents on innovation. See Bad Patents, or Bad Copyists?

***As a separate note, the Nov. 18-24, 2006 issue of the journal New Scientist features discovery and invention.

***The californiastemcellreport frequently includes mention of the circulation of newspapers.

--> On 3 Dec. 06: The Los Angeles Times, California's largest newspaper with nearly one million circulation, Sunday published an overview of the state's stem cell agency, headlined "Reality Check for Stem Cell Optimism."

--> On 6 Dec. 06: But some of that is what irritates its critics. Perhaps the harshest view came from Investors Business Daily, a financial newspaper with about 211,000 national circulation. In an editorial headlined "Fool's Gold Rush," the newspaper said,"Californians were promised wonder cures if they passed Proposition 71 to fund stem-cell research in 2004. Turns out they have bought a $3 billion jug of snake oil."

The Sacramento Bee, which has not said much recently about CIRM, published an editorial today that pressed for more public disclosure from the agency, a theme the paper was early to emphasize. The Bee, which has about 331,000 circulation in California's capital, said ...

--> On 22 April 06: Coverage of the decision was straight-forward with few surprises. Here is how the largest circulation paper in the state, the Los Angeles Times, ...

IPBiz isn't sure if californiastemcellreport has quoted circulation numbers for CapitolWeekly, which has been cited from time to time on the report. On 22 Sept 2005, there was an article Stem cell’s shell game? which alluded to the Baker / Deal report, disclosed prior to the vote on Proposition 71, which suggested California would received between $537 million and $1.1 billion from royalties and licensing from intellectual property. The CapitolWeekly article included the text:

"I know enough about federal funding of scientific research at universities to know that these claims of big financial windfalls to the state were ludicrous," said Jennifer Washburn, author of the book University, Inc.: The Corporate Corruption of American Higher Education.

Stem cell research is still in the very basic research stage, she said, when investments are unlikely to reap short-term payoffs.

"Basic research usually has broad-sweeping applications so it is difficult for any one company or any one state to capture all the financial benefits locally," Washburn added. "That’s why, traditionally, the federal government has always played a vital role in subsidizing basic research, not the states."

It concluded that it is unrealistic for the state to expect a huge payback on Proposition 71. The report examined federal policy over the last 25 years since the passage of the federal Bayh-Dole Act, which governs the use of federal funds at research at research universities. Bayh-Dole has been extremely good at pushing basic research, DeCillis said, but has established little track record for financial payoffs to the government. Numerous people, including scientists affiliated with the funding bodies created by Proposition 71, have cited Bayh-Dole as the proper model for stem cell research in California.

IPBiz notes that the Bayh-Dole Act isn't supposed to create "payoffs to the government." The Bayh-Dole Act allows non-profits (e.g., universities) to take title in patents AND to license the patents for the benefit of the non-profit (and the licensee). Although the federal government has certain march-in rights (when the patentee is not taking action) and can use inventions for the federal government, the plan of the Bayh-Dole Act is not to create payoffs to the federal government. Anyone who cited the Bayh-Dole Act as a model for California never intended California to get any money from the patents.

Klein also told Leavenworth that he did not disclose the problem with tax-exempt bonds to analysts who prepared an economic study touting the economic benefits of Prop. 71.

"Why didn't he?" Leavenworth wrote in a column. "Klein equivocated when asked that question. 'I'd want to go back and review this area,' he said, unable to provide more information.""Laurence Baker, a Stanford University professor who helped write the economic study, said he now wishes he had known that IRS rules could limit the receipt of royalties. Baker's study projected that stem cell research could bring in $537 million to $1.1 billion in royalties over 20 years.

"Now, says Baker, it appears that any royalties might be partly or completely offset by higher interest rate costs(which could run to $700 million).

On page 69 of the report, one finds the text: "Some state stem cell policies contemplate potential intellectual property issues... Policies that provide for states to share in the intellectual property associated with funded discoveries could potentially generate revenues for the states in the form of royalties for marketable therapies.

Page 70 does indeed have an error about patent life: "While patents typically have a 17 year life..."

Curiously, one will NOT find discussion of $537 million to $1.1 billion in royalties over 20 years (or even a reference thereto) in the Princeton paper by Laurence Baker.

***Of the re-exam of the WARF patents by FTCR and PubPat, note the post at setiathome:

"WARF was not the first to do human embryonic stem cell research," said Dan Ravicher, of the Public Patent Foundation. "They were just the first to run to the patent office and try to get such a broad patent."

The nonprofit Public Patent Foundation, made up of patent lawyers and scientists, will handle all the legal wrangling for the requested re-examination, Ravicher said.

At the time Thompson's first patent request was filed, "it was obvious to one of ordinary skill in the art of embryonic stem cell derivation that the process taught by (the earlier patent and published articles) could be used to isolate embryonic stem cells of other mammals, including humans," said Burnham Institute researcher Jeanne Loring, who filed a declaration to support the re-exam request.

Friday, January 26, 2007

PatentBaristas suggests the Ariad/Lilly case is like Rochester/Searle:

The University of Rochester asserted US 6,048,850 against Searle et al. in a case with many parallels to this one. If anything, claims in the ‘850 patent had more substance than those asserted here, since at least the ‘850 patent specified use of a class of compounds in its method of reducing a biological activity. Nevertheless, the Court of Appeals for the Federal Circuit affirmed the district court’s summary judgment holding the ‘850 invalid for failing to comply with the written description requirement of 35 USC 112 because it did not provide any guidance that would steer the skilled practitioner toward compounds that can be used to carry out the claimed methods - an essential element of every claim of that patent – and has not provided evidence that any such compounds were otherwise within the knowledge of a person of ordinary skill in the art at the relevant time…

On May 11, 2006, IPBiz had a post: Divergences between Ariad/Lilly and Searle/Rochester. In a nutshell, IPBiz noted: Rochester's problem was that it had no COX-2 inhibitor or a reasonable plan to make one. Ariad's problem is apt to be that there are too many prior compounds that fall within the scope of the method claims.

Although PatentBaristas writes "since at least the ‘850 patent specified use of a class of compounds in its method of reducing a biological activity," the problem was that the '850 patent didn't identify any member of the class (Rochester argued to the contrary, but was unconvincing.) What Rochester did have was a method to identify a member of the class. In effect, Rochester could tell you what a "wild turkey" was but couldn't tell you where to find one. If your patent claim is a method to eat a wild turkey Thanksgiving dinner, then Rochester's patent wasn't too helpful. Not surprisingly, it went down on summary judgment.

A Virgin-branded company will be launched next Thursday and is expected to offer parents the chance to put the umbilical blood of their newborn children into cold storage.

(...)

Public cord storage is becoming more common, particularly in the US, but there is also a growing private industry taking advantage of the promise of these cures. However, the industry is extremely controversial because the chances of developing a disease that stem cells can cure, such as leukaemia, is small while the new cures may never materialise.

(...)

This has not stopped more than 11,000 families in the UK using stem-cell storage facilities. The services typically cost about £1,500 for collection of the blood and about £100 a year for cold storage.

***IPBiz notes that the low probabilities of success have not stopped stem cell advocates, and some voters.

The Grambling State Provost has suspended publication of The Gramblinite because of poor quality, including factual errors and plagiarism. For its action, the school may be relying on the 2005 Hosty v. Carter decision, in which the 7th U.S. Circuit Court of Appeals ruled that limited freedom of expression rights applicable to high schools could be extended to colleges and universities.

Some analysts have suggested that the issuance of a PI suggests that BMS will prevail on the merits at trial. They overlook the deal BMS tried to make, and some of the possible legal complexities associated with the "chiral switch." Recall that amazon.com got a PI against Barnes & Noble.

***There is a very lengthy post at PatentBaristas discussing the Plavix matter (Is it Worth it for Generics to Challenge Branded Drugs? )

Within the post is the text: While it is true that basic active ingredient patents are challenged more and more frequently, no generic drug has been legally permitted to enter the US market before a branded drug’s initial active ingredient patent’s expiration

Among others, it might seem that Plavix itself is a counterexample to the assertion on PatentBaristas. PatentBaristas notes: In the Apotex case, the disputed patent, U.S. Patent No. 4,847,265, covers Plavix’s main ingredient and does not expire until 2011. As explicitly noted earlier in this IPBiz post: Apotex wasn’t required to recall the generic Plavix that was already in the market and branded Plavix sales sank 53 percent. Thus generic Plavix was legally permitted to enter the US market before the 2011 date of the expiration of the patent on the (+)-enantiomer of clopidogrel bisulfate. There may be some other counterexamples.

PatentBaristas also has a post: More On Ariad v. Lilly re Evista, Xigris. The post contains a discussion of a Lilly inequitable conduct defense based on failure to disclose references which were inherently anticipating:

Ariad asserted that, during the ‘516 prosecution, the Manual of Patent Examination Procedure instructed examiners that inherency required “contemporaneous recognition” (i.e., that the missing descriptive matter is not only necessarily present, but also that it would be recognized by those of ordinary skill). Ariad argued that there was no contemporaneous recognition here, that no one recognized that any of the various compounds cited reduced NF-kB activity.

The inherent anticipation argument is complicated because two separate lines of cases conflict on the issue of “contemporaneous recognition,” with each side citing cases that favor its interpretation.

Thursday, January 25, 2007

In an article entitled Stem Cell Reality Check and published Jan. 23, Malcolm Maclachlan noted the inconsistencies in outlook between the patent royalty projections of Stanford's Laurence Baker and those of Berkeley's Richard Gilbert. Interestingly, IPBiz had made the same points in a post published January 14. IPBiz notes CapitolWeekly didn't copy an earlier IPBiz post on Professor Noll's paper suggesting that large royalties were unlikely, possibly because Noll didn't explicitly mention, or comment upon, Baker's study.

Within the January 23 article is the text: "The study finds that stem cell research could be good for the people of California," Gilbert said. "But it is probably not going to make a lot of money for the people of California."

The January 23 article also says: This coming November, New York voters will decide on a $1 billion bond for stem cell research. In neighboring New Jersey, they'll vote on $500 million. [IPBiz hadn't heard this was included on NJ's ballot for 2007?!? IPBiz notes the Jersey Journal said on 12 Jan 07: TRENTON - Plans to ask New Jersey voters in November to approve borrowing at least $230 million for stem cell research will be considered this week by legislators who have promoted taxpayer investment into the potentially groundbreaking work. Voter approval would boost plans by Gov. Jon S. Corzine and Democrats who control the Legislature to make New Jersey a stem cell research leader, but would also increase state debt that has nearly doubled since 2000 to $29.7 billion. An article by David Chen in the New York Times on 15 Dec. 06 had stated: By comfortable margins, the State Senate and the General Assembly authorized borrowing $270 million to build the state's first stem-cell research centers in New Brunswick, Newark and Camden. Gov. Jon S. Corzine said on Thursday that he would enthusiastically sign it. Supporters hope the investment, paid for with the state's unused bonding capacity, will pay off with the recruitment of top researchers and the promise of federal funds should the Bush administration's ban on financing for embryonic stem-cell research be lifted. "What edge California thought they had, they've lost it," Mr. Cohen said.

Maclachlan didn't mention the Rutgers study about large stem cell royalties for NJ.

The January 23 article also states: On Tuesday, the Wisconsin Alumni Research Foundation [WARF] bowed to widespread pressure and loosened its licensing policies for three stem cell-related patents it owns, potentially giving up on royalties worth millions. Evidently, Maclachlan hasn't heard about 35 USC 271(e)(1) or Merck v. Integra.

Credit goes to John Simpson of the Foundation for Taxpayer and Consumer Rights, a Santa Monica non-profit. In July, Simpson and his group filed an official challenge to three WARF patents, with support from Jeanne Loring, a researcher at the Burnham Institute in La Jolla. They make a strong case that the U.S. Patent and Trademark Office should never have issued the patents.

The wedge between the pharma/biotech/manufacturing and the software/electronics views of the patent world is on one level just a normal development in a vibrant and growing field. But beyond a certain point, it is not a good sign. This is especially true when it is combined with the view that the current Supreme Court is anti-patent.

(...)

My reading of the evidence – including eBay and its aftermath – is that this is a pro-business Court. I think the Supreme Court has created, overall, a very moderate body of patent law in recent years.

(...)To summarize: I believe the Court looks at patent cases from a centrist, inclusive, business-oriented perspective, which is a far cry from saying they are anti-patent. Criticism of individual patents, as in the KSR oral argument, or the dissent from the dismissal of certiorari in Metabolite does not in my mind reveal an underlying anti-patent bias. It does reveal a concern with the quality of some individual patents – which is a different concern.

[IPBiz notes that CJ Roberts talked about the Federal Circuit never seeing a patent they didn't like at page 42 of the KSR transcript.]

But of course, in this the Court is not alone. Although it is tempting to say that those who are “anti-bad patents” are really in some sense “anti-patent,” I would disagree. As this is the core of the contentious divergence between pharma and electronics mentioned earlier, I turn to that issue now.

Wednesday, January 24, 2007

NAS on radon

In response to a statement by one IPBiz reader, another IPBiz reader commented:

Radon is not a "bogus" issue. In fact, more data exists about the risk of human exposure to radon than nearly any other airborne chemical. The National Academy of Sciences last looked at the issue in 1999, examining all available studies, and concluded radon causes over 20,000 deaths a year in the United States. There is no serious debate in the scientific community about the risk of radon. So why not test your home?

There are several issues raised by the comment of the commenting IPBiz reader:

#1. IPBiz itself was talking about Mayor Gilmore's placement of a radon detection cannister on a table on the first floor. IPBiz notes that that is not the right place to look for radon, a gas which is significantly heavier than air. IPBiz also notes that solid-phase daughter products (e.g., the long-lived lead daughter) can be the significant problem.

#2. An IPBiz reader (not IPBiz) raised the bogus issue, and now further states: Please note, that the respondent did not say if tobacco related lung cancer was "subtracted out" in the BIER-VI data. (After all, it is the largest lung cancer source.) The respondent did not describe the model, how it subtracted out the data.

I will admit, that if the K factor is truly equal to 1 for underground male smoking miners, as well as 3 year olds in non-smoking homes, then maybe the extrapolation from the high dose of miners, to the lower doses in homes, has some validity. So all the "art" is in the statistics for deaths by lung cancer for children in non-smoking homes...and I'll bet that number is very low. (In other words, one is subtracting two big numbers, and then parsing the residual among all other groups.

Lastly, in BIER-IV, (or its critics), there were concerns about nonlinear effects, radon PLUS smoking being more damaging than the sum of radon and smoking. (For instance, the radon daughters being bound to smoke particles in the lungs.) "The committee selected a linear-nonthreshold relationship..." means the assessment never proved it, they assumed it. It would appear they have no evidence for linearity at low doses.

I'd buy a junk science detector, before I bought a radon detector.

#3. The commenting IPBiz reader invoked an NAS study, and NAS studies are not necessarily deemed reliable references at IPBiz [below and in papers published by LBE]. The commenting IPBiz reader suggests that the 1999 study was the last NAS study on the topic ["last looked at the issue in 1999", which is untrue], but, in the following, consider what is, and is not in, the 1999 NAS report.

--The National Research Council has published the report, entitled: "Health Effects of Exposure to Radon: BEIR VI, Committee on Health Risks of Exposure to Radon (BEIR VI)". This report by the National Academy of Sciences (NAS) is the most definitive accumulation of scientific data on indoor radon. The report confirms that radon is the second leading cause of lung cancer in the U.S. and that it is a serious public health problem. The study fully supports EPA estimates that radon causes about 15,000 lung cancer deaths per year.--

This National Research Council's report of the sixth Committee on Biological Effects of Ionizing Radiations (BEIR VI) addresses the risk of lung cancer associated with exposure to radon and its radioactive progeny.

(...)

Risk models, which mathematically represent the relationship between exposure and risk, have been developed and used to assess the lung-cancer risks associated with indoor radon. For example, the precursor to this committee, the BEIR IV committee, developed one such model on the basis of statistical analysis of data from 4 epidemiologic studies of underground miners. The BEIR IV model has been widely used to estimate the risk posed by indoor radon. Since the 1988 publication of the BEIR IV report, substantial new evidence on radon has become available: new epidemiologic studies of miners have been completed, existing studies have been extended, and analysis of the pooled data from 11 principal epidemiologic studies of underground miners has been conducted involving a total of 68,000 miners and to date, 2,700 deaths from lung cancer.

Physical and biologic differences between the circumstances of exposures of male miners working underground and of men, women, and children in their homes could lead to differing doses at the same exposures. The committee estimated the value of a dimensionless parameter, termed the "K factor" in prior reports, that characterizes the comparative doses to lung cells in homes and mines for the same exposure. Using a model to estimate the dose to the cells in the lung, and incorporating new information on the input parameters of the model, the committee found that the doses per unit exposure in mines and homes were essentially the same. Thus, K is calculated to be about 1 for men, women and children (age 10 years), and slightly above K = 1 for infants (age 1). Consequently, a value of 1 was used in making the risk projections.

(...)The committee selected a linear-nonthreshold relationship relating exposure to risk for the relatively low exposures at issue for indoor radon. This assumption has significant implications for risk projections.

(...)On the basis of the epidemiologic evidence from miners and understanding of the genomic damage caused by alpha particles, the committee concluded that exposure to radon in homes is expected to be a cause of lung cancer in the general population. According to the committee's two preferred risk models, the number of lung-cancer cases due to residential radon exposure in the United States was projected to be 15,400 (exposure-age-duration model) or 21,800 (exposure-age-concentration model). Although these represent the best estimates that can be made at this time, the committee's uncertainty analyses using the constant relative risk model suggested that the number of cases could range from about 3,000 to 33,000.1 Nonetheless, this indicates a public-health problem and makes indoor radon the second leading cause of lung cancer after cigarette-smoking.

(...)The committee's model and general approach to assessing lung-cancer risks posed by indoor radon and cigarette-smoking are subject to considerable uncertainty because of gaps in our scientific knowledge of effects at low levels of exposure.

***

A 2004 report in Health Physics notes: The large United States county-based study ( Cohen 1995, 2001) in which an inverse relationship has been suggested between residential low-dose radon levels and lung cancer mortality has been reviewed. While this study has been used to evaluate the validity of the linear nonthreshold theory, the grouped nature of its data limits the usefulness of this application. Our assessment of the study's approach, including a reanalysis of its data, also indicates that the likelihood of strong, undetected confounding effects by cigarette smoking, coupled with approximations of data values and uncertainties in accuracy of data sources regarding levels of radon exposure and intensity of smoking, compromises the study's analytic power. The most clear data for estimating lung cancer risk from low levels of radon exposure continue to rest with higher-dose studies of miner populations in which projections to zero dose are consistent with estimates arising from most case-control studies regarding residential exposure.

****The discussion above raises many issues. There is no direct (i.e., autopsy) evidence that radon causes 20,000 deaths per year. This number comes from a model, which derives from data on deaths in miners who were exposed to far more than 4 pC/liter of radon. But let's consider the reliability of other NAS reports, specifically the NAS report on patent reform.

LBE published a footnote which included the following text concerning the "patent grant rate" numbers of Quillen and Webster, and the use thereof in a report by the National Academy of Sciences (NAS):

A post at groupsrv.com (topic: internal 3d laser engraving) noted: "The counting scheme generating these numbers is ridiculous." Of the use by the National Academy of Sciences of the Quillen/Webster data, one poster observed: "For whatever reason, the authors of the National Academies of Science and of Engineering choose to manipulate the data to make a point; and they did." While the NAS study utilizes comparisons between countries (as distinct from analyzing how the USPTO is following US rules, which is the issue), one notes patent prosecution in the US differs from foreign offices in so many ways regarding claim interpretation and application of prior art that they are not well suited for comparison, as Robert A. Clarke noted in 85 J. Pat. & Trademark Off. Soc'y [JPTOS] 335 (2003). A poster on a different board observed: Now if the question is how many patents are granted with their original claim set and with no prosecution history estoppel, I'd say the PTO is c! loser to 5-10%. Thus, in the saga of patent grant rate, in the legal world so dominated by the use of proxies, we have a situation in which the one guy at the USPTO and some other guys writing on internet boards were right, and the former General Counsel of a Fortune 100 company, the professor at a top 10 law school, and the National Academy of Sciences (in the April 2004 version of Stephen A. Merrill, Richard C. Levin, and Mark B. Myers, A Patent System for the 21st Century ) were wrong. It is a strange, strange world, and one in which things are not always what they seem to be.

In the final report by the National Academy of Sciences, the panel did not rely on the numbers of Quillen and Webster, but did rely on a perceived higher grant rate in the US relative to Japan and Europe to infer the presence of a patent quality issue in the United States. The NAS panel did not contemplate the impact of different rules among the US, Japan and Europe. The patent quality issue served as common ground to involve many players dissatisfied with the patent system to get traction for patent reform, in the body of HR 2795. However, disagreement over the injunction issue among major players killed off 2795. Of course, 2795 was disconnected from the fee diversion issue, which also went nowhere. In the end, the USPTO pretty much ended up where it started.

At no point did the NAS investigate the accuracy of the numbers of Quillen and Webster, or the reliability of the method used to generate them.

At the heart of the case is whether an "integer transform" is just another type of "discrete cosine transform" [DCT] or they are fundamentally different.

A transform is an algorithm used in video compression. Qualcomm's patented technology describes a method of video compression that calls for a discrete cosine transform. The H.264 standard and its products use an integer transform.

IPBiz notes a paper from MERL (Mitsubishi) which describes a method to convert DCT coefficients into IT coefficients. If there are a variety of ways to interconvert the coding schemes yielding different results, then the two coding schemes probably are not identical. The abstract of the MERL paper notes that MPEG-2 uses a DCT, but that H.264 uses an integer transform, itself suggesting the two are different. Separately, if Qualcomm is taking the position that "all schemes are the same," then is there invalidating prior art from a different scheme?

Specifically, Germany turns out to be a pioneer in the automotive sector, environmental technology, and renewable energy technologies. In growing fields such as computer technology, home entertainment systems, microelectronics, "red biotechnology" (such as stem cell research), however, Germany is far behind.

As the BCG puts it in a press release on the study, "When it comes to memory systems, image processing and displays, communication platforms, or IT applications, most of the patents and patents pending are from the US or Asia." In these sectors, the BCG found Germany that Germany is a "follower" that further develops new technologies for specific applications. According to the BCG, such a strategy can only be beneficial if fast product and investment cycles can be managed.

IPBiz wonders if BCG is counting the Hwang and Schatten applications in its assessment of "red technology." Merely counting noses without making an in-depth assessment is, well, ....

***Separately, of BCG -->

The following is taken from a manuscript by LBE about the ideas of Jaffe and Lerner, which was submitted to the journal IDEA (Franklin Pierce) which manuscript IDEA declined to publish:

Perhaps the most interesting aspect of the Stalk and Lachenauer analysis concerns something that wasn’t published in the book. Although the text in the Harvard Business Review did include a heading “plagiarize with pride,” a proposed book chapter heading “Plagiarize, don't shade your eyes” didn’t make it. The Economist wrote: With the editors at the Harvard Business School Press, the internal police at BCG [Boston Consulting Group] also balked at some of the language, chuckles Mr Stalk. One chapter heading, urging managers to "Plagiarise, don't shade your eyes", became "Take it and make it your own."

(...)

Management Today reviewed the concepts in the following way:

How many good ideas do you have a year, really? Who in your management team is a top performer and who is merely a makeweight? You probably don't have time to develop all your own talent and you certainly will not have a monopoly on all the good ideas. So - guess what - you are going to have to steal some.

IPBiz to Professor Thomas Field of Franklin Pierce (who wrote of Jaffe and Lerner: "Those who share my belief that two relative newcomers have little grasp of key problems, much less meaningful solutions, should not stand silent."): sorry Professor, but your own school won't publish commentary on Jaffe and Lerner. Look also on IPFrontline.

Reuters noted: Citing court documents filed late on Friday [Jan. 19], analysts said it appears that a rival anemia drug made by Roche called Mircera was made using the same amino acid sequence and composition as Epogen.

"We think this means Amgen's probability of winning its patent infringement case has increased dramatically," said Mark Schoenebaum, an analyst at Bear Stearns, in a research report.

Monsters and Critics noted: documents released last week indicate it`s a pegylated version of an EPO product.

M&C also noted: Michael Aberman acknowledged in a research report the documents rule out the possibility Roche uses a semi-synthetic manufacturing method for Mircera, which could have aided its case. But he goes on to note, 'Roche`s amended counterclaims provide details about the inequitable conduct argument and suggest to us that they could prevail.'

If this holds true, 'this would not only put all of Amgen`s existing EPO patents at risk but also put Roche`s anti-trust arguments into play,' Aberman stated. 'The net result is we are not changing our probability of Amgen`s success in the case.'

M&C also discussed possible implications of Democratic control of Congress:

To fund their proposal, Democrats are expected to recommend changes to biotech drug reimbursement covered under Medicare Part B, including accelerating follow-on biologics and reducing ASP+6 percent reimbursement.

'Both of these proposals may weigh on Amgen, since its blockbusters Epogen and Aranesp could get hit both on follow-on biologics (following Epo`s patent expiration in 2013), and on a reduction in ASP+6 percent in the nearer term (since these are somewhat discretionary drugs for doctors, who may end up losing money on these drugs if ASP+6 percent is reduced too much),' Reddoch stated.

Tuesday, January 23, 2007

Sankar Chatterjee, of Texas Tech University, in this week's online issue of Proceedings of the National Academy of Sciences, declares that the Microraptor gui is the clear evidence that nature and life itself have discovered a long time before humans the double-winged flight. He suggests that feathers from the legs of Microraptor gui would hinder flight if the small dinosaur were to fly like modern birds. Instead, the feathered legs of the two-pound dinosaur could have been held below the body in flight, creating two staggered wing sections, the upper one slightly ahead of the lower one.

"Aircraft designers have mimicked many of nature's flight 'inventions,' usually inadvertently," Chatterjee wrote. "Now, it seems likely that Microraptor invented the biplane 125 million years before the Wright 1903 Flyer."

Matthew Carrano, curator of dinosaurs at the Smithsonian's National Museum of Natural History, quoted by Associated Press, said that the question focuses on what the legs can do, and it's a difficult problem because the fossils are flat and require interpretation as to what they would have looked like in three dimensions.

To give a simple example, the invention of the Wright Brothers pertained to three-dimensional control of flight (not to powered flight, as some believe). Control of two dimensions was well-known before the Wrights, and, ailerons, an element that could control the third dimension (analogously to the wing warping of the Wrights) was also known before the Wrights. A, B, and C were all known. Did that make (A + B + C) obvious? Is the Federal Circuit's definition "absurdly narrow"? If so, propose a new one, rather than hiding with the confusion of the justices.

As a minor aside, the Wright's patent application, written by the Wrights, was filed months before the date of powered flight in December 1903.

Of the text about Microraptor --it seems likely that Microraptor invented the biplane--, the Wright Brothers didn't invent the biplane, they invented control of flight in three dimensions.

John Crace wrote in The Guardian the text: Whereas many students in text-based disciplines seem now to be almost paralysed by the possibility of inadvertently copying another person's work, our students [in visual arts] operate in a relatively pressure-free environment that allows them to develop their creativity without fear. But having said that, I do think students need to understand there are ethical implications for their work.

Also of some note is the text:

Not that there's much reason for Damien Hirst to care one way or the other. Art critics are only interested if he is in or out of fashion - whether his work is heartbreakingly hip or tiresomely last year. A Hirst is a Hirst is a Hirst, even if it looks almost identical to something else. Either way, his bank balance gives him the only reality check he needs. The Humbrol anatomy kit retailed for less than £15; Hymn was valued at about £1m. Dixon made next to nothing for True Daisy; the 500 prints of Valium sold for up to £10,000 each.

Thus one can have situations in which the "copy" is worth more than the original, not unlike themes in the Laurence Tribe plagiarism incident.

A press release states: Nano Chemical Systems Holdings, Inc. announced Jan. 23 that it has filed a US Patent application on a breakthrough new material that exhibits light (luminescent) in the absence of heat. This Nano-enhanced material sets a new standard for high efficiency and for increased brightness.

The press release also states:

Chemiluminescence is the production of light from a non-heat-generating chemical reaction; in short, light without fire. The firefly's biochemical chemiluminescent reaction is highly efficient, approaching the theoretical limit of one photon produced for each molecule involved in the reaction, producing 88 photons for each 100 molecules for a yield of 88%. Current man-made chemiluminescence uses chemical reactions that require a fluorescent molecule, a key intermediate, and a catalyst. They produce sustainable, instantaneous, highly visible light which, with specific doping, can allow for differing colors and intensities. Commercially valuable, man-made chemiluminescent reactions have efficiencies of only 23%.

The Company's present invention improves the efficiency of the reaction for making a chemiluminescent material whose chemo-fluorescent reaction's active period is controllable as a first-order function of humidity, thus reducing to a second order function the prior art's dependency on ambient temperature. The light emitted is intensified by using Nano-materials to achieve new level of brightness. But most amazingly, the material disappears after emitting light for as long as a 2-hour period, leaving almost no residue. Applications for this new, nano-enhanced material cut across industry lines and the Company plans to announce the introduction of the first commercial product based on this technology in the very near future.

Mayor Gilmore also appeared on Channel 29 on 22 Jan. setting out a cannister radon detector on the first floor of his home in Hamilton. If one really wants to look for radon, the basement is a better bet, as radon is way heavier than air. Also, radon doesn't have a long half-life, so one might worry about the radioactive lead isotope arising from the radon decay, which lead isotope has a half life of over 25 years and is apt to end up as a dusty solid which one ought to worry about. As a separate matter one IPBiz reader noted: by the way, most radon testing is "bogus", because the "threat" of radon is based on very very very poor data. The data is one study, circa 50's or so. Uranium miners (most of whom also smoked) had a higher lung cancer incidence. the investigators CLAIMED to be able to subtract two big numbers (all lung cancer deaths, and lung cancer deaths due to smoking), to get the much smaller number of deaths due to radon. (So, you also had to be a uranium miner to get radon deaths.) So lots of extrapolation, poor statistics, and not a very clean dose-response curve. As Reagan started to close down EPA lab studies, radon became the "justification" or "threat" that EPA hung its hat on.....

There is not much there, there. [In passing, IPBiz notes a connection between the last sentence and an opinion by DNJ Judge Garrett Brown relating to a certain computer science professor at Princeton University.]

Finally, there was much discussion of an NJ Senate proclamation commending Rutgers University for its 2006 football season. Coach Schiano and some fifth year seniors appeared at the NJ Capitol on Jan. 22. Some stories also noted that Rutgers is renegotiating the contract of Schiano. It is increasingly difficult to find mention of Vai Sikahema's August 2006 op-ed entitled "Rutgers is Wrong." Among other things, the Sikahema incident illustrates the extreme pliability of the internet. Inconvenient statements can be readily made to disappear. "Litera scripta manet" does NOT apply to the internet.

**UPDATE**

One day after the Proclamation, Channel 25 showed a NJ legislator (Baroni?) asking questions about "how much" money was being spent on football at a time when overall spending at Rutgers is dropping. His point was "why only football." Why not spend money on the sciences to be great in the sciences? Why not spend money on other sports to be great in them? The legislator's inquiry is more meaningful than was Sikahema's. The gist of Sikahema's argument was why spend money on Rutgers football when Rutgers is a known loser. Sikahema indicated that spending lots of money would be all right for Ohio State, Penn State, or BYU, who have successful programs, but spending money on Rutgers was a waste. Sikahema is wrong. Schiano proved that, if one spends a lot of money on a football program, someone (here Schiano) can win lots of games, specifically 11-2 in 2006. Sikahema's idea that this can only happen at select places, like Ohio State (go Florida), is just plain dumb. That said, the legislator's question is a good one. But the various articles on Rutgers football in the fall of 2006 have provided an answer. The legislator's inquiry won't get traction.

**UPDATE**

NJ PBS-TV (Channel 52) had a story on Jan. 24 on the money spent for Rutgers football. It included an interview with a student who said he was going to Rutgers because of the football team, and reports that applications for entry and transfer were both up this year (about 6 and 12% respectively). It mentioned that donations to the sports program were up. The story did not discuss whether there was a net gain.

'I know the type of person Lovie Smith is,' Dungy said Jan. 22. 'Lovie's got the same Christian convictions I have. He runs his team the same way. I know how those guys are treated in Chicago and how they play tough, disciplined football. There's none of the win-at-all-costs atmosphere.

'I think for two guys to show that you can win that way, I think that's just as important for the country to see.'

Monday, January 22, 2007

Industry-sponsored stem cell research will be facilitated by a new WARF policy that will enable companies to sponsor research at an academic or non-profit institution without a license, regardless of location and regardless of intellectual property rights passing from the research institution to the company. This will enable companies to get started with stem cell research in a low-cost, visible manner and increase funding of stem cell research by for-profit companies. Companies will still need a license when they want to bring the research into their company laboratories or when they want to develop a product for the market.

Given that stem cell research is within the area covered by the exemption of 35 USC 271(e)(1) as interpreted by Merck v. Integra, this isn't too surprising. Further, patentees, like bank robbers, go "where the money is."

Press release -->

JANUARY 22, 2007

FOR IMMEDIATE RELEASE

CONTACT: Andy Cohn Director of Government Relations and Public Relations Wisconsin Alumni Research Foundation (608) 263-2821

(Madison, WI) The Wisconsin Alumni Research Foundation (WARF) announced today three policy changes and clarifications that are expected to have a positive affect on stem cell research. The new policies will affect industry-sponsored stem cell research, academic and commercial licensing, and WARF’s relationship with the California Institute for Regenerative Medicine (CIRM), and will apply to current and future license agreements.

“WARF’s stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move the technology forward,” said Carl Gulbrandsen, managing director of WARF. “These latest changes reflect an ongoing dialog with researchers and university administrators across the country.”

Industry-sponsored stem cell research will be facilitated by a new WARF policy that will enable companies to sponsor research at an academic or non-profit institution without a license, regardless of location and regardless of intellectual property rights passing from the research institution to the company. This will enable companies to get started with stem cell research in a low-cost, visible manner and increase funding of stem cell research by for-profit companies. Companies will still need a license when they want to bring the research into their company laboratories or when they want to develop a product for the market.

“These policy changes should help universities engage industry sponsors in human embryonic stem cell research projects,” said Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University. “Our collective research efforts will benefit from this new approach.”

Second, while ensuring provisions related to informed consent for embryo donations are communicated and honored, WARF is changing the cell transfer provisions in its academic and commercial licensing. The new policy will allow easier and simpler, cost-free cell transfers among researchers. This will facilitate collaborations within the human embryonic stem cell research community and thus advance the field.

“These policy changes will facilitate further research and discovery in a very exciting area of life sciences,” said James Severson, vice provost of intellectual property and technology transfer at University of Washington. “WARF is a respected leader in moving science from the laboratory bench to the marketplace.”

WARF is also clarifying its position with regards to the California Institute for Regenerative Medicine (CIRM). As a not-for-profit, grant-making organization, CIRM does not require any license or agreement from WARF to pursue its grant making policies. Further, WARF does not expect CIRM to remit to WARF or WiCell any portion of payment that CIRM receives from its grantees. WARF has been and will continue to be supportive of CIRM’s efforts to fund human embryonic stem cell research and move the technology forward.

Stanford University and other academic and non-profit institutions in California are in the process of making proposals to CIRM for collaborative efforts in stem cell research, according to Katharine Ku, director of the Office of Technology Licensing at Stanford University.

“We are delighted to have such a clear statement from WARF about the intellectual property implications for institutions funded by CIRM and who uses cells from WARF,” Ku said. “We believe that the best way to advance knowledge and ultimately to commercialize stem cell technology for the benefit of human health is to allow non-profit organizations to pursue stem cell research without licensing constraints. This change in policy is a thoughtful, responsible approach to licensing these patents.”

The WARF policy changes are effective immediately. Documents reflecting these changes are now available on the WiCell and NIH Web sites (www.wicell.org and http://stemcells.nih.gov/research/registry, respectively.)

WARF holds the basic patents on James Thomson’s method of isolating and defining human embryonic stem cells and has made those rights available free of charge to academic researchers. WiCell Research Institute, a WARF subsidiary, hosts the National Stem Cell Bank, which provides cells from University of California–San Francisco, ES Cell International and WiCell.

WiCell has distributed cells to more than 360 research groups in 40 states and 24 countries. It has trained more than 350 scientists in how to work with the finicky cells. In a recent article in the journal Nature Biotechnology, Jason Owen Smith found that of all of the academic papers published in scientific journals between 2002 and 2004, a full 67 percent used cells from WiCell.

Over the past year, the number of WARF commercial licenses has doubled, reflecting an increase in industry-supported research and development. Geron, a WARF licensee, has announced that they will begin clinical trials using human embryonic stem cells later this year.

Last year, the institute [CIRM] said its grantees must give 25 percent of royalties to the state on discoveries that yield more than $500,000. That prompted Beth Donley, then a WARF attorney, to say at a biotech meeting in San Francisco that WARF may assert its patents and seek license fees from commercial partners of California grantees.

Though Donley's comment caused a stir among researchers in California, Andy Cohn said WARF never said the state itself would have to get a license. Monday's statement clarifies that.

"This will move the science forward," Cohn said of the three moves. "It will get more companies interested, and that will bring more funding to academic researchers."

Jim Downing at the Sacramento Bee wrote: In a peacemaking move, a Wisconsin foundation that holds several key embryonic stem cell patents announced Monday [Jan. 22] it would let scientists conduct their research without having to negotiate a license. Under the new policies announced Monday, California's stem cell institute and its grantees specifically will not be required to negotiate a license with the Wisconsin group. However, the foundation did not give up its right to claim a share of royalties from stem cell therapies developed using state funding that are eventually commercialized, spokesman Andy Cohn said.

Terri Somers wrote on January 23: Scientists expect access to human embryonic stem cells for research to improve thanks to new policies announced yesterday by a University of Wisconsin agency that controls the patents on the cells.

(...)

Researchers are also now free to provide their colleagues with copies of embryonic stem cells that they received from WARF.

“I couldn't even share cells with colleagues before, so this is good,” said Jeanne Loring, an embryonic stem cell researcher at the Burnham Institute in La Jolla.

Loring and two taxpayer advocate groups have filed a challenge of the WARF patents with the U.S. Patent and Trademark Office, citing exorbitant licensing fees [IPBiz: irrelevant in a re-exam] and arguing that Thomson's work was not unique enough to qualify for a patent [IPBiz: the stronger challenge is obviousness, not novelty, tho probably neither will work at the USPTO].

She suspects that the patent challenge and publicity about it contributed to the new policies. [IPBiz: the challenge didn't contribute; maybe the publicity did.]

But despite the policy changes, the patent challenge will not be dropped, said Loring and John Simpson, of the Foundation for Taxpayer and Consumer rights, one of the groups challenging the patents.

“A change in licensing policy of the human ES cell patents doesn't solve the fundamental problem that the patents should not have been issued in the first place,” Simpson said. “The right thing for WARF to do is admit that it doesn't deserve the patents and abandon them in their entirety.” [IPBiz: don't hold your breath, John.]

Harvard University researchers Kevin Eggan, Chad Cowan and Douglas A. Melton wrote members of Congress earlier this month to complain that the White House domestic policy office's report "Advancing Stem Cell Science Without Destroying Human Life" was a "misuse and misunderstanding" of their research. Excerpts:

"We are surprised to see our work on reprogramming adult stem cells used to support arguments that research involving human embryonic stem cells is unnecessary. On the contrary, we assert that human embryonic stem cells hold great promise to find new treatments and cures for diseases. . . .

***Separately, C&E News stated -->

The first policy change will allow industry-sponsored research to be done at academic or nonprofit institutions without a license from WARF. The sponsoring companies will still need to obtain a license once the work moves into company labs or the work enters the product development phase. Another change in policy will allow researchers to transfer WARF cells to others for free. Previously, such transfers required a license.

The final change clarifies WARF's position related to the California Institute for Regenerative Medicine (CIRM), a nonprofit, grant-making organization set up to distribute stem cell research funds created by the state's $3 billion bond initiative. The change clears CIRM to make grants to and collect funds from its grantees without remitting any payment to WARF.

"WARF's stem cell policies have evolved over the years, always in favor of increasing access and making it easier for scientists to move technology forward," said Carl E. Gulbrandsen, WARF's managing director. "These latest changes reflect an ongoing dialogue with researchers and university administrators across the country."

Sunday, January 21, 2007

Memphis' Channel 5 discusses the use of turnitin at the University of Memphis:

Here's how it works: When a student finishes a paper, he or she sends it in by computer to the Turnitin program set up by the university. The software checks the paper against a database of billions of articles. If anything is copied from another piece of work, the paper is returned to the professor with red marks.

Of course, turnitin does not detect copying; it detects similarities of the submitted article to the articles in the database. Turnitin does not know if the student copied, or "independently created." Given that university professors provide assignments in a relatively small number of topics (e.g., the scaffold business in business ethics), sooner or later, the database will fill up with all reasonably foreseeable ways of expressing thoughts on the small number of topics.

Under some embodiments of turnitin, the student can preview what turnitin finds. The Channel 5 report noted:

"The way I've used it, the system is open, so the students can submit their papers before they turn them in," said University of Memphis English professor Dr. Joshua Phillips.

Under his system, Phillips said, students can get their papers back, see where the red marks are, and then make the necessary changes before turning in the final product.

BARRIE: Look, I think the examples you've given today are the same sort of things that would flunk an English 1A student, you know, writing some term paper on the same type of subjects.

There is a similar issue about facts used in the book:

In a chapter entitled "The Holiest Sacrament, Abortion" there's a 25-word passage straight out of literature from Planned Parenthood. It had been taken virtually word-for-word, it is factual, concerns the president of the Mississippi Baptist Convention, but there is no credit given. In another chapter, entitled "The Creation Myth," Coulter manages another long passage, this one 24 words, that is neither hers nor attributed, this time in a passage about the galactic ruler Xenu.

IPBiz also noted differences between plagiarism and copyright infringement.

There is an article by Timothy B. Lee entitled Patent Law Confuses Application with Invention which appears at heartland.org.

The article discusses a number of cases but targets KSR:

Which brings us to November’s oral argument before the Supreme Court. Teleflex holds a patent that covers connecting a car’s gas pedal to its engine throttle electronically, rather than mechanically. The defendant, KSR International, argued that simply connecting two well-understood components was too obvious to merit a patent. The Federal Circuit ruled for Teleflex, holding that without specific documentation describing the connection of a gas pedal to an electric throttle, it could not declare the invention obvious.

That argument was not so well received by the Supreme Court, especially its conservative members. Justice Antonin Scalia called the Federal Circuit’s rule “irrational” and “gobbledygook.” When Teleflex’s attorney noted that his position is supported by the major patent bar associations, Chief Justice John Roberts retorted, “Which way does that cut? That just indicates that this is profitable for the patent bar.”

Of the "specific documentation" point, Lee wrote: [The CAFC] held that when a patent covers the combination of two elements, it can be declared obvious only if someone can produce another patent, an academic paper, or other formal documentation that pre-dated the patent application and had a specific “teaching, suggestion, or motivation” to combine the elements in the manner described.

Lee is wrong in stating that specific documentation must be found. In the CAFC case of In re Kotzab, decided in the year 2000 long before KSR v. Teleflex, the CAFC wrote:

the teaching, motivation, or suggestion may be implicit from the prior art as a whole. rather than expressly stated in the references... In re Kotzab, 217 F.3d 1365, 1370 (CAFC 2000)

On recalls that the Kotzab case was explicitly cited in the CAFC decision in the KSR case. As stated on IPBiz:

The 2005 decision of the Federal Circuit is not citable as precedent (nonprecedential). In ED Michigan, defendant KSR prevailed on a summary judgment motion for invalidity. Teleflex appealed for several reasons. One asserted an error of law based on an incorrect teaching-suggestion-motivation test. For prior art, the district court had relied on the Asano patent (5,010,782) and asserted that electronic controls (not taught by Asano) were well known in the art. In finding the district court's analysis wrong, the CAFC cited Kotzab, 217 F.3d at 1371, observing the district court was required to make specific findings as to whether there was a suggestion or motivation to combine the teachings of Asano with an electronic control in the particular manner claimed by claim 4 of the ’565 patent.

Without reaching into the nuances of patent law, the CAFC decision in KSR (which significantly is NONPRECEDENTIAL) relied on, and EXPLICITLY cited, In re Kotzab, so any "confusion" regarding the LACK of a requirement for a specific document to show motivation would have to be an intentional confusion. Another point worth noting is that the Federal Circuit didn't say the invention wasn't obvious; they merely said that there was no showing of motivation (i.e., there was a lack of evidence; not that there might not be evidence). For the requirement of motivation, the Federal Circuit cited In re Kotzab, which is the precedential case at issue (although certainly not the first case requiring motivation).

AND

As a followup, for a different "conservative" view on the case.

#1. A district court is required by law to follow the precedent of the relevant appellate court, here the Court of Appeals for the Federal Circuit.

#2. Here, the district court didn't bother to write down any reason that one of ordinary skill would combine the two parts of the combination invention as claimed by the patentee.

#3. In not writing down any reason, the district court violated controlling precedent, as expressed for example in In re Kotzab.

#4. As a separate matter, the Kotzab case states that motivation may be implicit in the prior art as a whole, rather than having to be found in one particular document. Thus, the burden of finding "something" to write down was not high.

#5. The Federal Circuit sent the case back to the district court, to write something down. The Federal Circuit did not say that the invention wasn't obvious. They said the district court didn't follow the law.

#6. Talking about "how obvious" the invention at issue may be is interesting, but irrelevant to what happened here, as there was no ruling that the invention wasn't obvious. The district court flaunted controlling precedent, which it is not at liberty to do. The Supreme Court has the power to change the precedent of the Federal Circuit, but the district court does not.

***Although the question of whether or not the invention in the KSR case is obvious was NOT at issue before the Federal Circuit, one notes that the Federal Circuit has to fashion law that applies to a variety of cases. Thinking about a different case is instructive. Right now, three of the Thomson (WARF) patents on human stem cells are being challenged. The challengers say that Thomson merely followed a "recipe" that had been created for mouse stem cells. Years and years passed between the time of the mouse recipe and the isolation of a human stem cells. Obvious?

Of "obviousness" in the scientific realm, the journal Science published two papers in the area of SCNT to create human embryonic stem cells. The reviewers and editors passed judgment that the submitted manuscripts were entirely plausible, based on scientific principles. They weren't. Significantly, one year has passed since the fraud was uncovered, and not one lab in the whole world has been able to duplicate the results of the first paper, much less the second paper. Was the considered judgment of the scientific community "obviously" wrong?

***Finally, it is ironic to note that the opinions on patents of the conservative community of 2007 bear a striking resemblance to the opinions of two liberal icons, Black and Douglas, as they were expressed for example in the Graver Tank case back in 1950.

***UPDATE. 24 Jan.**

To date, no response or comment has appeared in response to my postings on techliberation. It is interesting to note that when the facts of the KSR case are laid out, the people who talk about the absurd definition of obviousness of the Federal Circuit have nothing to say. Reminds IPBiz a bit of Game 7 of Mets v. Cardinals in 2006. [from the Boston Globe: Beltran took a called first strike, fouled the next pitch at the plate, then never moved as Wainwright's slow curve cut through the strike zone. ``You have good moments and bad moments in your career," Beltran said afterward. ``This was a bad moment, one I'll have to live with the rest of my life."]The obviousness critics never move when the KSR facts appear.

The Jan. 21 Newark Star-Ledger has a story titled "Drugmaker near end of patent debacle" which begins:

Bristol-Myers Squibb and Sanofi-Aventis will be in federal court this week to defend the patent on blood-thinner Plavix -- the final act in a bizarre melodrama that has caused severe financial pain and helped topple a chief executive.

The story also said:

Bristol-Myers and Sanofi are widely expected to win their patent case. In an earlier ruling, Judge Stein tipped his hand, saying the brand-name drugmakers would likely prevail in their patent-infringement lawsuit against Apotex.

***The New York Times picked up a Reuters story, which included the text:

In opening arguments in Federal District Court in Manhattan, Evan Chesler, a lawyer for Sanofi and Bristol-Myers, said Apotex had no legal basis for its argument that the drug’s patent should be invalidated.

“They have basically rewritten history,” he said, arguing before Judge Sidney H. Stein, who is hearing the case without a jury.

But an Apotex lawyer, Robert Breisblatt, said the patent should not stand, in part because the drug formula would have been obvious to another scientist in the field.

IPBiz notes that neither paper mentioned the enantiomer/racemate "chiral switch" issue with Plavix. IPBiz wonder how all the "patent reformers" pontificating about KSR v. Teleflex would come out in this case, if they understood what happened in the Plavix matter.

Apotex has been challenging the patent since 2002, arguing it is not truly innovative but is based on the patent for a molecule which expired in 2003 and which provided information on how to make clopidogrel bisulfate, Plavix's chemical name.

AND

Many pharmaceutical analysts have predicted Sanofi and Bristol will prevail in the patent infringement trial, in large part because Judge Stein previously granted a preliminary injunction in their favor.

The following comments are from civilwarmemory about the responsibility of the reviewers.

-->We reviewers read a manuscript for its merits, and we do our best, but we don't have the months necessary to read every book and article on a topic, or the years that would be required to track down every cited source. Nor does an academic press have the resources to hire fact checkers to do the same thing. UT did its best--blame the author.-->All presses and reviewers operate from the assumption that they are reviewing original manuscripts (I can't imagine how one checks for plagiarism when reviewing a manuscript. Unless you happen to be familiar with a book (like Marvel was with his own study of Andersonville) it is not realistic to expect a press or a reviewer to catch plagiarism. Let's keep the responsibility on the authors. Moreover, the review process at UT and other academic presses works 99% of the time. The system is sound and it almost always produces high quality scholarship. Let's not overreact to this unfortunate incident It probably can also be said that patent examiners don't have "the months necessary to read every book and article on a topic, or the years that would be required to track down every cited source." On average, they have about 18 hours to process each application, from start to finish. Academic reviewers, as well as patent examiners, are selected based on their general familiarity with the topic they are reviewing/examining. If they can't spot attempts to republish prior work, we are in trouble.

Reviewers of history or of science probably start with the proposition that they are reviewing original (and non-fraudulent) manuscripts. However, patent examiners don't start with such a proposition. They routinely reject applications over prior art and they reject applications for non-enablement. The patent examiner has a tougher job.

**comment to civilwarmemory**

I have enjoyed the comments but disagree slightly on some points.

Of the comment --we don't have the months necessary to read every book and article on a topic, or the years that would be required to track down every cited source--, reviewers who have some familiarity with the topic will not require months or years to determine if something is amiss. For example, it took a matter of minutes to demonstrate that the gist of "Lost Triumph: Lee’s Real Plan at Gettysburg—and Why it Failed" had been previously published, in among other places, The Cavalry Battle that Saved the Union: Custer vs. Stuart at Gettysburg. Other people, such as D. Scott Hartwig, reached similar conclusions merely by utilizing their own individual knowledge. [The Gettysburg point is about priority, not about plagiarism, but does illustrate that a reviewer need not spend great amounts of time to evaluate a situation.]

Of the point about not enough time to --track down every cited source--, cite checkers at law reviews are supposed to verify the accuracy of every cited source. Of course, cite checkers at the Stanford Law Review allowed through an assertion that Gary Boone invented the integrated circuit (rather than Bob Noyce and Nobel Laureate Jack Kilby).

As a different point, having the person "most familiar with the work" review the work (as here with William Marvel reviewing the work of Fred Ruhlmann) is not always the best course, as there can be conflicts of interest. [this is a general observation; Marvel behaved admirably here] The issue was illustrated in an early episode of "Law and Order" entitled "Big Bang," wherein the reviewer gave an unfavorable review and stole the work of the submitter.

As an additional point, many academics are not familiar with the differences between plagiarism and copyright infringement. As the Dastar case illustrated, it is NOT a violation of federal law to claim authorship of a public domain work. Thus, one is free to claim authorship of Hamlet, or "It's a Wonderful Life."

Further to an earlier IPBiz post [ MBA students: the biggest cheaters?], IPBiz did a search on "scaffold plank incident" (of relevance to business ethics) and reached a site to download papers entitled "duenow." The description was as follows:

Business Ethics Analysis (873 Words)

Summary / Excerpt: The paper takes on a case called Scaffold Plank Incident, and takes two out of three approaches on Ethics to evaluate the case and reach a decision for Bob in the case. The book in reference is Organizational Theory, Design, and Change, Fourth Edition by Gareth R. Jones. The paper has been done in APA style of work. It has been revised for changes in some sentences

***Separately

Southern New Hampshire University's Christos and Mary Papoutsy Distinguished Chair in Ethics will present a seminar on Feb. 6 about "What Every Business Leader Needs to Know About Intellectual Property, But Was Afraid to Ask."

"We have done the extensive lab analysis, and there is nothing conclusive as to a particular chemical signature from the samples we took," said Charles Sturcken, a spokesman for the city’s Department of Environmental Protection. Pressed for details on what the city was doing next, Sturcken said that unless the bad smell returned, it was finished with the matter. "The investigation of the odors from last Monday has been concluded," he wrote in an e-mail.

(...)

To date, investigators in both states say they have no idea what the gas was or where it came from and are largely out of leads to check. "Odors are elusive," Makatura said.

IPBiz notes that extensive lab analysis could not detect a mercaptan, or other sulfur compound, is a bit scary. IPBiz previously noted that many news organizations immediately related the smell to [odorless] natural gas, not contemplating the reality that natural gas by itself doesn't smell (a sulfur compound is added) or the possibility that the perceived compound might have originated other than from natural gas.

--On Monday [Jan. 15], the National Academy of Sciences released a two-year study, "Earth Science and Applications from Space: National Imperatives for the Next Decade." We can count polar bears, stick thermometers in the ocean, and measure the hair on wooly caterpillars, but the only way to find out what's going on with global warming is to study Earth from space. The Academy report finds that NASA's earth science budget has fallen by 30 percent, while the number of operating Earth-observing instruments on NASA satellites will fall by 40 percent by 2010. The funds are being siphoned off to prepare for a manned science station on the moon. NASA seems unable to describe just what science will be done.--

IPBiz was expecting some comment by Park as to his statements about stem cells on Jan. 12. Sadly, the cupboard was bare. IPBiz had noted:

Bob Park wrote on WN on 12 Jan. 07:

The bill lifts the President's ban on using leftover stem cells from fertility clinics in research. (...)A Presidential veto will spare leftover embryonic stem cells from the indignity of saving human lives and allow them to be thrown in the garbage with their dignity intact.

IPBiz notes to Bob Park-->

on the science: Fertility clinics (e.g., those doing IVF) are in the business of handling eggs and embryos. They don't do stem cells, and thus don't have leftover embryonic stem cells to hand over.

on the politics: In 2001, Bush restricted federal funding to stem cell lines already in existence. Bush didn't ban the use of eggs/embyros; where do you think ACT got their material for their research?

Matthew Nisbet, a scholar at American University, wrote that the public still scores relatively low in both knowledge of the science and the politics involved, and Park's WN illustrates both points.

**Can Park tell the difference between an embryo, a stem cell, and a wooly caterpillar?

***A remark in the Sacramento Bee on the planned departure of Zach Hall from CIRM was of interest:

At times, Hall could have done more to solicit opinions and respond to the agency's critics, but given his background -- he came from the insular National Institute of Health -- he's gone further than many would have expected.

Also, ACT announced that it had received a "momentous" $204,439 NIH research grant [that's federal dollars, folks] in conjunction with a project involving one of the company's academic partners, the Burnham Institute in the San Diego area. californiastemcellreport noted: It is fair to say that the releases are as much – if not more – about creating a "good story" for investors about ACT than the science. Nothing wrong with that. That's the way business works. IPBiz asks if "good story" is a synonym for "fairy tale"? The stemcellreport separately quoted Matt Gardner on IP: That's a huge issue for this industry. And the biggest thing to focus on there is that the U.S. Congress is going to visit this issue in 2007. What needs to be kept in mind here is that this industry is built on certainty in intellectual property. Anything that any of our public sector partners do to try and draw that into question will be harmful to this industry, no matter what it looks like. "Most of these companies, when they are initially funded, are done so on a very clear picture of their intellectual property. Because it may be 15 years before you have product revenue based on the amount of time it takes to develop a product, run clinical trials and get the product approved, everything until then is a value based on intangible assets.

IPBiz has separately noted the questioning done by Professors Gilbert and Noll of the rosy predictions made about patent royalty income that were made BEFORE Proposition 71 was passed. IPBiz notes that post-Proposition 71 everyone seems to understand the timeline for development of patent royalties. While the Supreme Court debates obviousness in KSR v. Teleflex, one might contemplate the concept of "obviously wrong."

About Me

I'm a patent lawyer located in central New Jersey. I have a J.D. from the University of Chicago and a Ph.D. from Stanford University, where I studied graphite intercalation compounds at the Center for Materials Research. I worked at Exxon Corporate Research in areas ranging from engine deposits through coal and petroleum to fullerenes. An article that I wrote in The Trademark Reporter, 1994, 84, 379-407 on color trademarks was cited by Supreme Court in Qualitex v. Jacobson, 514 US 159 (1995) and the methodology was adopted
in the Capri case in N.D. Ill. An article that I wrote on DNA profiling was cited by the Colorado Supreme Court (Shreck case) and a Florida appellate court (Brim case). I was interviewed by NHK-TV about the Jan-Hendrik Schon affair. I am developing ipABC, an entity that combines rigorous IP analytics with study of business models, to optimize utilization of intellectual property. I can be reached at C8AsF5 at yahoo.com.